UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009851
Receipt number R000011542
Scientific Title Development of the genetic diagnosis system of congenital and Inherited skin disorders
Date of disclosure of the study information 2013/01/25
Last modified on 2022/08/01 13:36:42

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Basic information

Public title

Development of the genetic diagnosis system of congenital and Inherited skin disorders

Acronym

Development of the genetic diagnosis system of congenital and Inherited skin disorders

Scientific Title

Development of the genetic diagnosis system of congenital and Inherited skin disorders

Scientific Title:Acronym

Development of the genetic diagnosis system of congenital and Inherited skin disorders

Region

Japan Asia(except Japan)


Condition

Condition

congenital and Inherited skin disorders

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To develop a genetic diagnosis system for congenital and Inherited skin disorders using next generation sequencers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

By this method, we can analyze multiple gene mutations by a single analysis.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Having skin diseases that could be congenital or inherited

Key exclusion criteria

Having non-congenital skin disorder

Target sample size

8050


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Ito

Organization

Keio University School of Medicine

Division name

Department of Dermatology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-3353-1211

Email

yoshihiro.ito@keio.jp


Public contact

Name of contact person

1st name Akiharu
Middle name
Last name Kubo

Organization

Keio University School of Medicine

Division name

Department of Dermatology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

akiharukubo@gmail.com


Sponsor or person

Institute

Department of Dermatology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Dermatology, Keio University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Center for Child Health and Development

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University Hospital

Address

35 Shinanomachi, Shinjuku, Tokyo

Tel

03-5363-3503

Email

akihiro.mitsunaga@adst.keio.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

旭川医科大学医学部皮膚科学講座
北海道大学病院皮膚科
慶應義塾大学医学部附属病院
国立成育医療研究センター
東京医科大学病院皮膚科
東邦大学医療センター大森病院皮膚科
帝京大学医学部附属病院皮膚科
けいゆう病院皮膚科
群馬大学医学部附属病院皮膚科
平塚市民病院皮膚科
株式会社日立製作所日立総合病院皮膚科
獨協医科大学埼玉医療センター皮膚科
獨協医科大学医学部皮膚科
日野市立病院皮膚科
浜松医科大学医学部附属病院皮膚科
福井大学医学部附属病院皮膚科
富山大学医学部附属病院皮膚科
富士宮市立病院皮膚科
静岡県立総合病院皮膚科
新潟大学医歯学総合病院皮膚科
岐阜大学医学部附属病院皮膚科
信州大学医学部附属病院皮膚科
石川県立中央病院皮膚科
三重大学医学部皮膚科
京都大学医学部附属病院
神戸大学医学部附属病院皮膚科
大阪市立大学医学部附属病院皮膚科
加古川中央市民病院皮膚科
兵庫県立淡路医療センター皮膚科
兵庫県立加古川医療センター皮膚科
川崎医科大学附属病院皮膚科
川崎医科大学総合医療センター皮膚科
四国こどもとおとなの医療センター
高知大学医学部附属病院皮膚科
香川大学医学部附属病院皮膚科
産業医科大学病院皮膚科
大分大学医学部附属病院皮膚科
福岡市立こども病院皮膚科
Quy Hoa National Leprosy Dermatology Hospital (ベトナム)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 25 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

We identified that mutations in SERPINB7 cause Nagashima-type palmoplantar keratosis.

Results date posted

2020 Year 01 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Suspended

Date of protocol fixation

2013 Year 01 Month 10 Day

Date of IRB

2012 Year 10 Month 11 Day

Anticipated trial start date

2013 Year 01 Month 25 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Under searching genetic mutations in hereditary skin diseases.


Management information

Registered date

2013 Year 01 Month 23 Day

Last modified on

2022 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011542


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name